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在ResMed工作了数年，专注于医疗设备软件开发后，我们发现一个始终阻碍工程效率的因素就是文档。不是设计，也不是测试。SOUP评估、测试报告。对于开发团队来说，这通常意味着：需要花费数周时间在代码之外进行上下文切换，手动重写已经存在于代码库、测试和工单中的信息，在发布之前需要等待文档的完成（每月或每年的发布）。我们推出了Qualtate，一个基于AI的自动化医疗设备软件文档平台，首要功能包括：SOUP文档，测试报告和证据生成。实际上，这将数周的手动文档工作缩短为几分钟，利用AI从现有的工程文档中提取、结构化并生成合规的文档。我们的目标不是用“AI”来降低质量或合规性，而是让开发人员能够专注于软件交付，同时仍能生成通过审计的文档。监管要求每年都在增加，AI的应用在这里似乎是不可避免的。我们希望让它对工程师有用，而不是成为另一个拖慢他们的工具。我们正在向希望影响下一步自动化内容的团队开放早期访问。欢迎提出技术问题、顾虑或质疑。网站上有演示。https://qualtate.com/

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After several years building medical device software at ResMed, one thing consistently blocked engineering velocity: documentation.Not design. Not testing. SOUP assessments, test reports.For dev teams, this usually means:Weeks of context switching away from codeManually rewriting information that already exists in repos, tests, and ticketsWaiting on documentation before releases can move forward (monthly or yearly releases).We’re launching Qualtate, an AI-powered platform that automates medical device software documentation, starting with:SOUP documentationTest reports and evidence generationIn practice, this turns weeks of manual doc work into minutes, using AI to extract, structure, and generate compliant documentation from existing engineering artifacts.The goal isn’t to “AI-away” quality or compliance. It’s to let developers stay focused on shipping software, while still producing documentation that passes audits.Regulatory requirements increase every year. AI adoption here feels inevitable. We’re trying to make it useful for engineers—not another tool that slows them down.We’re opening early access to teams who want to influence what gets automated next.Happy to answer technical questions, concerns, or skepticism.Demo on website. https://qualtate.com/

将数周的医疗设备文档转化为几分钟。